Dermal and transdermal cryogenic microprobe systems
Medical devices, systems, and methods optionally treat dermatological and/or cosmetic defects, and/or a wide range of additional target tissues. Embodiments apply cooling with at least one small, tissue-penetrating probe, the probe often comprising a needle having a size suitable for inserting through an exposed surface of the skin of a patient without leaving a visible scar. Treatment may be applied along most or all of the insertable length of an elongate needle, optionally by introducing cryogenic cooling fluid into the needle lumen through a small, tightly-toleranced lumen of a fused silica fluid supply tube, with the supply tube lumen often metering the cooling fluid. Treatment temperature and/or time control may be enhanced using a simple pressure relief valve coupled to the needle lumen via a limited total exhaust volume space.
1 . A system for treating a nerve associated with a target tissue of a patient, the system comprising:
a needle having a proximal end, a distal end, and a lumen therebetween, the needle comprising a 16 gauge or smaller needle size;
a cooling fluid supply lumen extending distally within the needle; and
a handpiece body having a size and shape suitable for supporting in a hand of an operator, the handpiece body comprising:
a cooling fluid source coupleable to the supply lumen to direct cooling fluid flow into the needle lumen so that liquid from the cooling fluid flow vaporizes within the target tissue when the needle extends into the target tissue so as to cryogenically treat the nerve, the cooling fluid source comprising a single-use cartridge contained in the handpiece body; and
a supply valve disposed between the supply lumen and the cooling fluid source, wherein the supply valve comprises a power source disposed within the handpiece for transitioning the supply valve transitions between a first configuration and a second configuration, wherein the supply valve vents the cooling fluid flow in the second configuration,
wherein the supply lumen is defined by a non-metallic tubular supply tube having an outer diameter less than 800 μm.
2 . The system of claim 1 , wherein the needle comprises a 25 gauge or smaller needle size, and has a tip suitable for penetrating a skin surface.
3 . The system of claim 1 , wherein the supply lumen is defined by the supply tube comprising fused silica, wherein the supply tube further has a polymer coating over the fused silica.
4 . The system of claim 1 , wherein the supply tube extends in cantilever distally into the needle lumen, and wherein the supply tube has sufficient stiffness to inhibit flow induced buckling of the supply tube within the needle lumen.
5 . The system of claim 1 , wherein the supply lumen has an inner diameter of less than 100 μm.
6 . The system of claim 1 , wherein an aspect ratio defined by an insertable length of the needle to an outer size of the needle is more than 20.
7 . The system of claim 1 , further comprising a pressure relief valve in fluid communication with the needle lumen so as to control a pressure of the vaporizing cooling fluid flow within the needle such that a temperature of the target tissue is within a desired treatment temperature range.
8 . The system of claim 7 , wherein an exhaust volume is between the supply lumen and the pressure relief valve and is less than 0.05 in 3 .
9 . The system of claim 7 , wherein the cooling fluid flow is metered primarily by a flow resistance of the supply lumen, and the metered flow inhibits temperature fluctuation by maintaining a liquid/gas mixture within the needle lumen.
10 . The system of claim 7 , wherein the cooling fluid flow is not actively modulated between the fluid source and the needle lumen during cooling, wherein the pressure relief valve comprises a biasing spring mechanically urging a valve member against a valve seat so as to maintain pressure within the needle lumen within a desired pressure range, and wherein the biasing spring is disposed outside an exhaust volume extending from the supply lumen to the valve seat.
11 . The system of claim 1 , further comprising a cooling fluid supply volume between the needle lumen and the supply valve, wherein the valve in the first configuration provides fluid communication between the fluid source and the supply volume, wherein the valve in the second configuration inhibits the cooling flow and vents the supply volume so as to limit cooling fluid vaporization within the needle lumen after the valve moves from the first configuration to the second configuration.
12 . The system of claim 1 , further comprising:
the handpiece body supporting the needle; and
at least one distally oriented skin engaging surface supported by the handpiece body so as to engage the skin surface before, during and/or after cryogenically treating the nerve to warm the skin surface.
13 . The system of claim 1 , wherein, when the cooling fluid flow is initiated, an outer surface of the needle engaging the target tissue cools at a rate of more than 25° C./sec so as to promote intracellular ice formation and necrosis of the nerve.
14 . The system of claim 1 , further comprising an array of needles coupled to the fluid source, each needle, when the cooling fluid flow is initiated, having an outer surface that cools at a rate of more than 25° C./sec so as to promote intracellular ice formation and necrosis of the target tissue between the needles.
15 . The system of claim 1 , wherein the cooling fluid, when vaporizing within the needle lumen cools an outer surface of the needle to a temperature in a treatment temperature range throughout an insertable length of the needle between the distal end and the proximal end such that the nerve can be treated.
16 . The system of claim 1 , further comprising:
a second needle having a proximal end, a distal end, and a second needle lumen therebetween, the second needle comprising a 16 gauge or smaller needle size; and
a second cooling fluid supply partially disposed within the second needle lumen, the second cooling fluid supply comprising a fused silica tube having a polymer coating, and wherein the cooling fluid source is coupleable to the second cooling fluid supply to direct cooling fluid flow into the second needle lumen so as to cryogenically treat the nerve.
17 . The system of claim 16 , further comprising a single tubing structure coupled to the cooling fluid source and the cooling fluid supply tubes.
18 . The system of claim 1 , wherein cryogenically treating the nerve comprises alleviating pain of the patient associated with the nerve.
19 . A system for treating a nerve associated with a target tissue of a patient, the system comprising:
a needle having a proximal end, a distal end, and a lumen therebetween, the needle comprising a 16 gauge or smaller needle size;
a cooling fluid supply lumen extending distally within the needle; and
a handpiece body having a size and shape suitable for supporting in a hand of an operator, the handpiece body comprising:
a cooling fluid source coupleable to the supply lumen to direct cooling fluid flow into the needle lumen so that liquid from the cooling fluid flow vaporizes within the target tissue when the needle extends into the target tissue so as to cryogenically treat the nerve, the cooling fluid source comprising a single-use cartridge contained in the handpiece body, wherein the supply lumen is defined by a supply tube comprising fused silica, wherein the supply tube further has a polymer coating over the fused silica,
wherein the supply lumen is defined the silica supply tube having an outer diameter less than 800 μm.
20 . A system for treating a nerve associated with a target tissue of a patient, the system comprising:
a needle having a proximal end, a distal end, and a lumen therebetween, the needle comprising a 16 gauge or smaller needle size;
a cooling fluid supply lumen extending distally within the needle; and
a handpiece body having a size and shape suitable for supporting in a hand of an operator, the handpiece body comprising:
a cooling fluid source coupleable to the supply lumen to direct cooling fluid flow into the needle lumen so that liquid from the cooling fluid flow vaporizes within the target tissue when the needle extends into the target tissue so as to cryogenically treat the nerve, the cooling fluid source comprising a single-use cartridge contained in the handpiece body; and
a pressure relief valve in fluid communication with the needle lumen so as to control a pressure of the vaporizing cooling fluid flow within the needle from an intermediate treatment pressure to a target treatment pressure such that a temperature of the target tissue is within a desired treatment temperature range,
wherein the supply lumen is defined by a non-metallic tubular supply tube having an outer diameter less than 800 μm,
wherein the supply lumen is defined by the supply tube comprising fused silica, wherein the supply tube further has a polymer coating over the fused silica.